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Archivist and Document Control Specialist

2 months ago

Trenton, New Jersey, United States Smithers Full time

Smithers PDS LLC, a leading pharmaceutical development services company, is seeking a highly skilled Archivist and Document Control Specialist to join our team at our Ewing, NJ site. This is an on-site position with regular working hours.

  • Manage archives for GLP study related documentation, ensuring compliance with regulatory requirements and company standards.
  • Coordinate long-term archiving with external facilities, retrieve documents as needed, and maintain a secure short-term archiving area.
  • Participate in client and regulatory visits, providing expert knowledge and support.

Key Responsibilities:

  • Administer and track the standard operating procedure (SOP) system, including issuing, distributing, formatting, and archiving SOPs and associated controlled documents.
  • Maintain databases, such as deviations, methods, notebooks, training records, and provide monthly metrics.
  • Support the creation of new hire training binders and training records.
  • Assist with coordination of client visits, including travel arrangements, scheduling of conference rooms, and greeting visitors.
  • Provide administrative support to site executives, including coordination of meetings, travel arrangements, and other activities as needed.

Additional Position Responsibilities:

  • Provide assistance with phone coverage for the main line.
  • Recognize problems and notify management of resolution for issues within scope of responsibility and expertise.
  • Write and review SOPs and policies/procedures for Archiving activities.
  • Coordinate and schedule departmental training sessions and prepare training materials.
  • Support and participate in new hire pre-boarding and on-boarding processes.
  • Monitor office supplies and place orders when necessary.
  • Receive POs after material receipt is confirmed and work with accounts payable to ensure vendors receive proper payment.
  • Communicate the arrival of onsite visitors to relevant staff for both expected and unexpected vendor/client events.
  • Assist as a backup for receiving both goods and services through the backdoor entrance.

Qualifications:

  • Bachelor's degree in a related field or equivalent experience.
  • Knowledge of GLP regulations or toxicology/life sciences.
  • Proficiency in MS Office Suite, email applications, databases, and Internet searches.
  • Previous experience in archives, quality assurance, and/or standard operating procedure maintenance is desired.
  • Exceptional organizational and recordkeeping skills.
  • Demonstrated leadership and communication skills.
  • Attention to detail.